FDA.reportPublic FDA data

Application 065205

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUMTABLET, CHEWABLE;ORAL200MG;EQ 28.5MG BASENoNo
002AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUMTABLET, CHEWABLE;ORAL400MG;EQ 57MG BASENoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065205-001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2005-02-09
A065205-002AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORALRS2005-02-09

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A065205-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2005-02-0984e616aacf4f…
2026-09-14 22:38:342026-08A065205-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORALRS2005-02-0984e616aacf4f…
2026-08-18 06:07:402026-07A065205-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2005-02-09caaa826d4ba7…
2026-08-18 06:07:402026-07A065205-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORALRS2005-02-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065205-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2005-02-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065205-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORALRS2005-02-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065205-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2005-02-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065205-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORALRS2005-02-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A065205-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2005-02-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065205-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORALRS2005-02-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065205-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2005-02-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065205-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORALRS2005-02-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065205-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2005-02-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065205-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORALRS2005-02-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065205-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2005-02-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065205-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORALRS2005-02-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065205-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2005-02-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065205-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORALRS2005-02-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065205-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2005-02-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065205-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORALRS2005-02-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065205-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2005-02-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065205-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORALRS2005-02-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065205-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2005-02-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A065205-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORALRS2005-02-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065205-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2005-02-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065205-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORALRS2005-02-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065205-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2005-02-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065205-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORALRS2005-02-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065205-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2005-02-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065205-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORALRS2005-02-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065205-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2005-02-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065205-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORALRS2005-02-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065205-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2005-02-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065205-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORALRS2005-02-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065205-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2005-02-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065205-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORALRS2005-02-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065205-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2005-02-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065205-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORALRS2005-02-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065205-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG;EQ 28.5MG BASETABLET, CHEWABLE / ORAL2005-02-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065205-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG;EQ 57MG BASETABLET, CHEWABLE / ORALRS2005-02-0974a2ff9319b5…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 8 · 158 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMREMEDYREPACK INC.a26f2ceb-bb9b-4813-9691-6343381868602026-08-31Warnings, Adverse reactionsName fallback
brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMSportpharm LLC69e45bc0-de57-4603-a9eb-335988dfe0bf2026-08-29Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMREMEDYREPACK INC.e5b0770d-1301-498e-a4ed-41874d7bf2252026-08-27Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.7526a33a-18d6-36ca-e053-2a91aa0ab9f92026-08-26Warnings, Adverse reactionsName fallback
brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions4937611d-bd61-4538-ad1e-bd67e95279552026-08-25Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.1bda03a2-6c7d-4c9e-b98a-e5e01bebb3b12026-08-24Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMREMEDYREPACK INC.c88b2b50-c664-43b3-9c37-f134a329dc212026-08-14Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMREMEDYREPACK INC.80bef3fd-4f6f-4190-8865-9ac46c8947a32026-08-14Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.a1d6bf78-4bb7-469e-ba39-318e14aaee292026-08-13Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMAurobindo Pharma Limited3ae0c95f-7ffa-4317-9fea-4d07b86bee722026-08-13Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.fbd40fcd-bf5b-e91e-e053-6394a90a609c2026-08-12Warnings, Adverse reactionsName fallback
brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPreferred Pharmaceuticals Inc.2c7a4de8-002a-472c-90d8-4c39a1f188c32026-07-31Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
amoxicillin and clavulanate potassiumAMOXICILLIN AND CLAVULANATE POTASSIUMChartwell RX, LLC00b86913-50c8-443f-8467-f4f499d358af2026-07-23Warnings, Adverse reactionsName fallback
brand name: amoxicillin and clavulanate potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMREMEDYREPACK INC.77b82fac-3f6e-44c9-8dcc-362f01ad7a4b2026-07-21Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPreferred Pharmaceuticals Inc.1127a41b-14a1-4fe8-ae37-67ea5d7603012026-07-16Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMREMEDYREPACK INC.6e1c6209-660f-4043-b6a6-eac5f7665ef92026-07-15Warnings, Adverse reactionsName fallback
brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMHAWAII REPACK, INC.7fb0f56e-c098-49e4-b075-2eb8936582aa2026-07-13Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMUSAntibiotics, LLC7d4dfd6f-bd1a-4acc-8506-07fca08f8a382026-07-07Warnings, Adverse reactionsName fallback
brand name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMUSAntibiotics, LLC45c60b69-1b65-01ed-e063-6294a90a57be2026-07-07Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutionsce488c24-2ec5-4d1b-b446-90f2497aa15d2026-07-06Warnings, Adverse reactionsName fallback
brand name: Amoxicillin and Clavulanate Potassium

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-2270Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2270Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2270Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2270Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2272Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2272Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2272Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2272Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42814ORIG2008-07-31